Madison ENT and Facial Plastic Surgery, New York, NY, USA.
ENT Associates of Texas, McKinney, TX, USA.
Rhinology. 2024 Jun 1;62(3):310-319. doi: 10.4193/RhinRhin23.377.
Temperature-controlled radiofrequency (TCRF) device treatment of nasal valve dysfunction (NVD) was superior to a sham procedure control in reducing the symptoms of nasal airway obstruction (NAO) in this randomised controlled trial (RCT).
Two-year outcomes for 108 patients actively treated in a prospective, multicenter, patient-blinded RCT were used to determine treatment effect durability and changes in medication/nasal dilator usage. A responder was defined as ≥ 20 reduction in NOSE score or 1 reduction in severity class.
The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) women. Baseline NOSE score was 76.3. The 2-year responder rate was 90.4% and NOSE score treatment effect was -41.7; 54.7% improvement. Of 57 patients using medications/nasal dilators at baseline, 45 (78.9%) either stopped all use (33.3%) or stopped/decreased (45.6%) use in >=1 class at 2 years. Concurrent septal deviation, septal swell body, or turbinate enlargement did not significantly affect the odds of exhibiting a NOSE score of ≤ 25 at 2 years.
TCRF device treatment of NVD resulted in significant and sustained improvements in the symptoms of NAO at 2 years, accompanied by a substantial reduction in medication/nasal dilator use.
在这项随机对照试验(RCT)中,与假手术对照相比,温度控制射频(TCRF)设备治疗鼻阀功能障碍(NVD)可更有效地减轻鼻腔气道阻塞(NAO)症状。
使用 108 例积极接受前瞻性、多中心、患者盲法 RCT 治疗的患者的两年结局来确定治疗效果的持久性和药物/鼻腔扩张器使用的变化。应答者定义为 NOSE 评分降低≥20 或严重程度分级降低 1 级。
患者的平均(SD)年龄为 48.5(12.3)岁;66 例(61.1%)为女性。基线 NOSE 评分为 76.3。两年的应答率为 90.4%,NOSE 评分治疗效果为-41.7;改善 54.7%。在基线时使用药物/鼻腔扩张器的 57 例患者中,有 45 例(78.9%)在两年时停止了所有使用(33.3%)或停止/减少(45.6%)至少一种类别的使用。同期鼻中隔偏曲、鼻中隔肿胀体或鼻甲增大并不显著影响两年时 NOSE 评分≤25 的可能性。
TCRF 设备治疗 NVD 可显著且持续地改善 NAO 症状,同时药物/鼻腔扩张器的使用也大幅减少。